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11C-HY-2-15 Radiotracer for Tauopathies

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of Pennsylvania

Disqualifiers: Pregnancy, Schizophrenia, Alcohol abuse, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses a special imaging substance to help doctors see abnormal protein deposits in the brains of people with certain neurological diseases. It targets patients with MSA, PD, PSP, and healthy volunteers to compare results. The substance works by lighting up problem areas in the brain on a scan.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

How is the 11C-HY-2-15 radiotracer different from other drugs for tauopathies?

The 11C-HY-2-15 radiotracer is unique because it is designed for imaging tau proteins in the brain, which are associated with neurodegenerative diseases like Alzheimer's. Unlike traditional treatments that aim to reduce symptoms, this radiotracer helps visualize tau deposits, potentially aiding in diagnosis and understanding of the disease.¹ ² ³ ⁴ ⁵

Research Team

Eligibility Criteria

Adults aged 40-80 with Multiple System Atrophy (MSA), Parkinson's disease (PD), progressive supranuclear palsy (PSP), or healthy volunteers can join. Participants must understand the study and consent, or have a partner to assist. Brain donation is optional for PD/MSA/PSP subjects.

Inclusion Criteria

Participants must be informed of the investigational nature of this study and be willing to provide written informed consent

Participants must be willing to participate in this study in accordance with institutional and federal guidelines

Participants who are deemed unable to provide informed consent must have a designated study partner present for consent and to accompany them to study visits

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Exclusion Criteria

Contraindication to MRI, such as non-compatible implanted medical device

You have a serious mental illness like schizophrenia or bipolar disorder. Having major depression is okay.

You have a history of serious alcohol or drug problems.

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET Imaging

Participants undergo 11C-HY-2-15 PET scan to determine biodistribution, metabolism, excretion, and brain uptake. May include brain MRI and neurological assessments.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after PET imaging, including collection of adverse events.

4 weeks

Treatment Details

Interventions

11C-HY-2-15 (Radiotracer)

Trial OverviewThe trial tests a new brain imaging agent called 11C-HY-2-15 in MSA patients compared to those with PD, PSP, and healthy individuals. It involves neurological assessments, PET scans for amyloid and alpha-synuclein proteins, and MRI of the brain.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: 11C-HY-2-15 PETExperimental Treatment4 Interventions

Participants will undergo 11C-HY-2-15 PET scan, they may also have a brain MRI and Amyloid PET scan as well as neurological assessments

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania

Findings from Research

The novel PET tracer 18F-RO-948 shows superior binding characteristics for detecting tau pathology in Alzheimer's disease compared to other tracers 11C-RO-963 and 11C-RO-643, based on human evaluations involving amyloid PET-positive AD subjects and healthy controls.

In the study, 18F-RO-948 effectively discriminated between Alzheimer's patients and healthy individuals, revealing significant differences in tau accumulation across multiple brain regions, indicating its potential as a valuable tool for diagnosing and understanding Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of 3 Novel Tau Radiopharmaceuticals, 11C-RO-963, 11C-RO-643, and 18F-RO-948, in Healthy Controls and in Alzheimer Subjects.Wong, DF., Comley, RA., Kuwabara, H., et al.[2019]

The novel compound [18F] JNJ-64326067 shows promise for detecting tau aggregates in the brain, with significant retention observed in 4 out of 5 participants with probable Alzheimer's disease, indicating its potential efficacy in identifying neurodegenerative changes.

The dosimetry results suggest that [18F] JNJ-64326067 has a low effective dose for both males and females, making it a safe option for imaging tau pathology in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of [18F] JNJ-64326067, a novel candidate PET tracer for the detection of tau pathology in Alzheimer's disease.Schmidt, ME., Janssens, L., Moechars, D., et al.[2021]

Dynamic PET imaging with the tau radiotracer [18F]PI-2620 effectively distinguishes patients with progressive supranuclear palsy (PSP) from healthy controls, with a high accuracy demonstrated by area under the curve (AUC) values around 0.96.

Truncated acquisition times of 0-40 minutes provide a good balance of accuracy and efficiency for tau-PET imaging, maintaining similar discrimination capabilities as the full 60-minute scans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of short imaging protocols for [18F]PI-2620 tau-PET in progressive supranuclear palsy.Song, M., Scheifele, M., Barthel, H., et al.[2022]